MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA TITANIUM 4.5 VITALIUM ROD 4.5 X 600 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 48132601

Device Problems Mechanical Jam (2983); Naturally Worn (2988)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/18/2016

Event Type  malfunction  

Event Description

It was reported that; complaint concerning implants.Update (6-may-2016): originally purpose of the surgery was for a fusion for t10 to pelvis using a robot (competitive product) original purpose was not for any product failure however upon removal of the product, the surgeon experienced difficulty.The rod worn to set screws and pedicle screws interface were worn making them difficult for removal.Doctor said cobalt chrome rod is too hard for the metal and the titanium screw head interface.

Manufacturer Narrative

Catalog# 48132601.Method: risk assessment.Result: no devices were received back, so testing and inspection could not be performed to aid in root cause analysis.The devices implanted are meant to provide rigid support during fusion and as a result must provide strong engagement to one another.Conclusion: because no devices were received back, a root cause could not be determined conclusively.

Event Description

It was reported that; complaint concerning implants.Update (6-may-2016): originally purpose of the surgery was for a fusion for t10 to pelvis using a robot (competitive product) original purpose was not for any product failure however upon removal of the product, the surgeon experienced difficulty.The rod worn to set screws and pedicle screws interface were worn making them difficult for removal.Doctor said cobalt chrome rod is too hard for the metal and the titanium screw head interface.

• Brand Name: XIA TITANIUM 4.5 VITALIUM ROD 4.5 X 600 MM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5648346
• MDR Text Key: 45116099
• Report Number: 0009617544-2016-00183
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540448897
• UDI-Public: (01)04546540448897
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48132601
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1